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FDA 510(k)

LOW PROFILE STEERABLE-INTRAOPERATIVE

K-Number: K833248 · 1983-12-22

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1983-12-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE STEERABLE-INTRAOPERATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833248. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW PROFILE STEERABLE-INTRAOPERATIVE?

LOW PROFILE STEERABLE-INTRAOPERATIVE is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K833248.

When did LOW PROFILE STEERABLE-INTRAOPERATIVE receive FDA 510(k) clearance?

LOW PROFILE STEERABLE-INTRAOPERATIVE received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833248.

Who is the listed applicant for LOW PROFILE STEERABLE-INTRAOPERATIVE?

The FDA 510(k) record lists Advanced Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW PROFILE STEERABLE-INTRAOPERATIVE?

The FDA product code for LOW PROFILE STEERABLE-INTRAOPERATIVE is LIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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